New National Standard of Canada CAN/CSA-Z Canadian medical device reprocessing

Transcription

1 New National Standard of Canada CAN/CSA-Z Canadian medical device reprocessing Gale Schultz BN, RN 2018 Canadian Standards Association. All Rights Reserved.

2 Nine CSA MDR standards now in one book! 2

3 New and Improved! Streamlines content ( pages ) Removes redundancies Improves readability and flow Updates technical content where needed New content on preparation and maintenance Better aligns with the MDRD workflow Annexes streamlined and updated 3

4 CSA Standards Development Process 4

5 Who needs this standard? Everyone who reprocesses reusable medical devices (hospitals, dental offices, foot care, ophthalmology offices, etc.) Search the Z314 pdf to find sections specific to your needs 5

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7 Clauses Foundation for the Standard Preface (administrative) 0 Introduction (Informative) 1 Scope (Informative) 2 Reference publications (Informative) 3 Definitions (Normative) 7

8 Clause 4 General requirements Start of technical requirements Spaulding s criteria (New) All devices shall be cleaned before further reprocessing (disinfection or sterilization). Made risk assessment normative Critical Semi- Critical Non- Critical 8

9 Clause 5 Quality management system (QMS) Key performance indicators Leadership and planning Process and service quality Provision of resources Human Resources Operations (New) Environmental conditions and infrastructure 9

10 Clause 6 Personnel Staff and manager qualifications Occupational health and safety Infection prevention and control Personal protective equipment 10

11 Clause 7 Manufacturer s instructions for use (MIFUs) Medical devices need clear, validated MIFUs Ensuring ability to perform reprocessing Information supplied with sterilization containers 11

12 Clause 8 Evaluation and purchase Reusable medical devices Reprocessing equipment Sterile barrier systems Consumables 12

13 Clause 9 Loaned, reusable medical devices Prohibits user modification Must use licensed devices Documentation Requirements for coordination and timing 13

14 Clause 10 Work areas and design Physical space and location of reprocessing equipment Lighting (new) Environmental cleaning Clean and sterile storage Case cart management Traffic and environment controls Environmental cleaning 14

15 Clause 11 Decontamination of reusable medical devices Handling of contaminated devices Retrieval and transport Sorting and disassembly Prep for cleaning Cleaning, rinsing and drying Disinfection Respiratory devices 15

16 Clause 12 Flexible endoscopes Reprocessing area External providers Reprocessing endoscopes Storage Sterilization Accessories Damaged devices Quality assurance and records 16

17 Clause 13 Ultrasound transducer probes Reprocessing area Reprocessing ultrasound transducer probes Quality assurance and recordkeeping 17

18 Clause 14 Preparation of medical devices for reprocessing Instrument care and handling Drying Verification of cleanliness and functionality Lubrication Additional preparation requirements for steam and chemical sterilization 18

19 Clause 15 Selection and use of sterile barrier systems Evaluation and purchase Packaging system qualifications Product design Assembly Labelling Pouches and reels Wrappers Rigid sterilization containers 19

20 Clause 16 Sterilization methods Covers steam and chemical Dust covers Sterility assurance Routine monitoring IUSS Table-top steam sterilization 20

21 Clause 17 Storage, transportation, and distribution Transportation Storage Distribution Sterile storage area Physical and functional requirements Environmental cleaning Handling Transportation and distribution Emergencies 21

22 Clause 18 Equipment maintenance and quality assurance Table-top sterilizers Ethylene oxide Submicron water filters Repair or refurbishing Utilities (steam, feed water) 22

23 Clause 19 Selection and use of gowns and drapes Evaluation and purchase of reusable gowns and drapes Selection of gowns and drapes Use of gowns and drapes Containment and handling of soiled gowns and drapes at the point of use 23

24 Clause 20 Laundering, maintenance, and preparation of reusable gowns, drapes, and wrappers Laundry equipment and personnel Work areas and equipment Prevention of stains and other damage Maintenance Handling, transport, receiving, and storage of soiled and clean textiles Laundering Preparation and packaging 24

25 The Annexes Supporting information 19 annexes 18 provide guidance for implementation of mandatory content 1 (Annex E) is mandatory covering information to be supplied by the manufacturer 25

26 Thank you! CAN/CSA Z can be purchased at Type Z314 in the Search field 26

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